Malignant Solid TumourPhase 1NCT01951846
To Determine the Maximum Tolerated Dose (MTD) of BIBF 1120 in Patients With Solid Tumours
A Phase 1 study testing BIBF 1120 in people with Malignant Solid Tumour, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The primary objective of this study was to determine the maximum tolerated dose (MTD) of BIBF 1120 in patients with solid tumours by the monitoring of drug-related adverse events. Secondary objectives were the evaluation of safety, efficacy, pharmacokinetics, and pharmacodynamics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumour
- What is being tested?
- BIBF 1120
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2002to Nov 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
- Evaluable tumour deposits by one or more techniques (X-ray, CT, MRI, ultrasound)
- Age 18 years or older
- Life expectancy of at least three months
- Patients had to give written informed consent (which must be consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) and local legislation)
- Eastern Cooperative Oncology Group (ECOG) performance score < 2
- Full recovery from all therapy-related toxicities from previous chemo-, hormone-,immuno-, or radiotherapy
Who cannot join
- History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, or injuries with incomplete wound healing
- Pregnancy or breastfeeding
- Active infectious disease
- Brain metastases requiring therapy
- Absolute neutrophil count less than 1500 / mm3
- Platelet count less than 100 000 / mm3
Show all 16Show fewer
- Bilirubin greater than 1.5 mg / dl (> 26 μmol / L, International System of Units (SI unit) equivalent)
- Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
- Serum creatinine greater than 1.5 mg / dl (> 132 μmol / L, SI unit equivalent)
- Uncontrolled, severe hypertension
- Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
- Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
- Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
- Patients unable to comply with the protocol
- Active alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Tumorbiologie, Abteilung Internistische Onkologie
Freiburg im Breisgau, 79106
About this study
Official title: An Open Label Dose Escalation Study of BIBF 1120 Administered Orally for Four Weeks in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
The primary objective of this study was to determine the maximum tolerated dose (MTD) of BIBF 1120 in patients with solid tumours by the monitoring of drug-related adverse events. Secondary objectives were the evaluation of safety, efficacy, pharmacokinetics, and pharmacodynamics.
- Conditions
- Malignant Solid Tumour
- Being tested
- BIBF 1120
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBF 1120Drug
| Study group | Role | What they receive |
|---|---|---|
| BIBF 1120 | Experimental | Not described Receives: Drug: BIBF 1120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of BIBF 1120
Measured: up to 30 days
Secondary outcomes (8)
Overall best investigator assessment of tumour response
Measured: up to 4 months
Overall best calculated assessment of tumour response
Measured: up to 4 months
Time to tumour progression
Measured: up to 4 months
Change in Eastern Cooperative Oncology Group (ECOG) score
Measured: up to 4 months
Number of patients with response in transfer of contrast medium into tissue (Ktrans)
Measured: up to 4 months
Number of patients with response in initial area under the curve for first 60 seconds after onset of gadolinium uptake (iAUC60)
Measured: 60 seconds
Mean plasma level of vascular endothelial growth factor (VEGF)
Measured: 10 hours after drug intake
Mean plasma level of basic fibroblast growth factor (bFGF)
Measured: 10 hours after drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startNov 2002
- Primary completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumourStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951846
- Sponsor's protocol ID
- 1199.1
- Status last verified
- Sep 2013
- First submitted
- 17 Sep 2013
- Last updated
- 27 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Dose Escalation Study of BIBF 1120 Administered Orally for Four Weeks in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
- ClinicalTrials.gov ID
- NCT01951846
- Acronym / sponsor ID
- 1199.1
- Conditions
- Malignant Solid Tumour
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Nov 2004 (actual)
- First posted
- 27 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study was to determine the maximum tolerated dose (MTD) of BIBF 1120 in patients with solid tumours by the monitoring of drug-related adverse events. Secondary objectives were the evaluation of safety, efficacy, pharmacokinetics, and pharmacodynamics.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBF 1120 | Experimental | Drug: BIBF 1120 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
- Evaluable tumour deposits by one or more techniques (X-ray, CT, MRI, ultrasound)
- Age 18 years or older
- Life expectancy of at least three months
- Patients had to give written informed consent (which must be consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) and local legislation)
Key exclusion criteria (16 listed)
- History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, or injuries with incomplete wound healing
- Pregnancy or breastfeeding
- Active infectious disease
- Brain metastases requiring therapy
- Absolute neutrophil count less than 1500 / mm3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIBF 1120 | Drug | BIBF 1120 |
Primary outcome
Maximum tolerated dose of BIBF 1120
Time frame: up to 30 days
8 secondary outcomes
Overall best investigator assessment of tumour response
Time frame: up to 4 months
Overall best calculated assessment of tumour response
Time frame: up to 4 months
Time to tumour progression
Time frame: up to 4 months
Change in Eastern Cooperative Oncology Group (ECOG) score
Time frame: up to 4 months
Number of patients with response in transfer of contrast medium into tissue (Ktrans)
Time frame: up to 4 months
Number of patients with response in initial area under the curve for first 60 seconds after onset of gadolinium uptake (iAUC60)
Time frame: 60 seconds
Mean plasma level of vascular endothelial growth factor (VEGF)
Time frame: 10 hours after drug intake
Mean plasma level of basic fibroblast growth factor (bFGF)
Time frame: 10 hours after drug intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIBF 1120 in people with Malignant Solid Tumour, run by Boehringer Ingelheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of BIBF 1120 (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2013.